US5480436AExpiredUtility

Method for preventing tissue adhesion

91
Assignee: OSTEOTECH INCPriority: Apr 24, 1992Filed: Jul 15, 1994Granted: Jan 2, 1996
Est. expiryApr 24, 2012(expired)· nominal 20-yr term from priority
Inventors:Dirkjan BakkerErica A. BakkumClemens A. Van Blitterswlijk
Y10T428/249978B32B 27/24Y10T428/249976Y10T428/249988B32B 27/08A61L 31/06Y10T428/249992B32B 27/065A61L 31/148A61B 2090/0816Y10T428/249989Y10S521/916B32B 2535/00B32B 5/32A61B 90/00B32B 2307/7163A61L 31/146B32B 7/02
91
PatentIndex Score
137
Cited by
8
References
22
Claims

Abstract

A device for preventing adhesions or binding of tissue to tissue or of tissue to bone which comprises a composite of a first layer and a second layer, each of which comprises a biodegradable polymer, such as, for example, a polyethylene glycol/polybutylene terephthalate copolymer. The first layer is selected from the group consisting of a non-porous layer and a porous layer having a pore size no greater than 3 mu . The second layer has pores which have a pore size of from about 30 mu to about 250 mu . The device is placed between two tissues or between tissue and bone. Such a composite device provides for tissue growth into the second layer, while the first layer acts as an adhesion-preventing barrier, and enables attachment of the device to tissue without suturing. Alternatively, the device comprises the first layer hereinabove mentioned and a second layer which is an adherence layer and which adheres to tissue and/or bone.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
       1. A process for preventing the binding of tissue to tissue or of tissue to bone, comprising: placing between two tissues or between tissue and bone a device comprising a composite of a first layer and a second layer, wherein each of said first layer and said second layer comprises a biodegradable segmented copolymer which comprises a first component which is a polyalkylene glycol, and a second component which is a polyester formed from an alkylene glycol having from 2 to 8 carbon atoms and a dicarboxylic acid, wherein said first layer is selected from the group consisting of a non-porous layer and a porous layer in which essentially all of the pores have a pore size no greater than 3μ, and wherein said second layer includes pores having a pore size of at least about 30μ.   
     
     
       2. The process of claim 1 wherein said polyalkylene glycol is selected from the group consisting of polyethylene glycol, polypropylene glycol and polybutylene glycol. 
     
     
       3. The process of claim 2 wherein said polyalkylene glycol is polyethylene glycol. 
     
     
       4. The process of claim 1 wherein said polyester is selected from the group consisting of polyethylene terephthalate, polypropylene terephthalate, and polybutylene terephthalate. 
     
     
       5. The process of claim 4 wherein said polyester is polybutylene terephthalate. 
     
     
       6. The process of claim 1 wherein said biodegradable segmented copolymer is a polyethylene glycol/polybutylene terephthalate copolymer. 
     
     
       7. The process or claim 1 wherein said polyester is comprised of units having the following structural formula: ##STR7## wherein n is from 2 to 8, and each of R 1 , R 2 , R 3  and R 4  is hydrogen, chlorine, nitro-, or alkoxy, and each of R 1 , R 2 , R 3 , and R 4  is the same or different. 
     
     
       8. The process of claim 1 wherein said second layer includes pores having a pore size of from about 30μto about 250μ. 
     
     
       9. The process of claim 1 wherein said polyalkylene glycol is present in said copolymer in an amount of from about 30 wt. % to about 80 wt. %. 
     
     
       10. The process of claim 9 wherein said polyalkylene glycol is present in said copolymer in an amount of from about 50 wt. % to about 80 wt. %. 
     
     
       11. The process of claim 1 wherein said polyester is present in said copolymer in an amount of from about 20 wt. % to about 70 wt. %. 
     
     
       12. The process of claim 11 wherein said polyester is present in said copolymer in an amount of from about 20 wt. % to about 50 wt. %. 
     
     
       13. A process for preventing the binding of tissue to tissue or of tissue to bone comprising: placing between two tissues or between tissue and bone a device comprising a composite of a first layer and said second layer, said copolymer being a segmented thermoplastic copolymer comprising a plurality of recurring units of a first component and of a second component, wherein said first component comprises from about 30 wt. % to about 80 wt. %, based on the weight of said copolymer, of units having the formula:   --OLO--CO--R--CO--, wherein L is selected from the group consisting of a divalent radical remaining after removal of terminal hydroxyl groups from a poly(oxyalkylene)glycol, and a polymer including a first moiety and a second moiety, said first moiety being a polyalkylene glycol and said second moiety being selected from the group consisting of glycine anhydride, alloxan, uracil, 5,6-dihydrouracil, glycolic acid, lactic acid, and lactones, and said second component comprises from about 20 wt. % to about 70 wt. %, based upon the weight said copolymer, of units having the formula:   --OEO--CO--R--CO--, wherein E is an organic radical selected from the group consisting of a substituted or unsubstituted alkylene radical having from 2 to 8 carbon atoms, and R is a divalent radical remaining after removal of carboxyl groups from a dicarboxylic acid, wherein said first layer is selected from the group consisting of a non-porous layer and a porous layer in which essentially all the pores have a pore size no greater than 3μ, and said second layer includes pores having a pore size of at least about 30μ.   
     
     
       14. The process of claim 13 wherein L is a poly(oxyalkylene)glycol selected from the group consisting of poly(oxyethylene)glycol, poly(oxypropylene)glycol, and poly(oxybutylene)glycol. 
     
     
       15. The process of claim 14 wherein said poly(oxyalkylene)glycol is poly(oxyethylene)glycol. 
     
     
       16. The process of claim 13 wherein E is an alkylene radical having from 2 to 4 carbon atoms. 
     
     
       17. The process of claim 16 wherein said second component is selected from the group consisting of polyethylene terephthalate, polypropylene terephthalate, and polybutylene terephthalate. 
     
     
       18. The process of claim 17 wherein said second component is polybutylene terephthalate. 
     
     
       19. The process of claim 13 wherein L is poly(oxyethylene)glycol, and said second component is polybutylene terephthalate. 
     
     
       20. The process of claim 13 wherein said first component is present in the copolymer in an amount of from about 50 wt. % to about 80 wt. %. 
     
     
       21. The process of claim 13 wherein said second component is present in the copolymer in an amount of from about 20 wt. % to about 50 wt. %. 
     
     
       22. The process of claim 13 wherein said second layer includes pores having a pore size of from about 30μ to about 250μ.

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